Batch BT-020811
Veranide XR • SGP • L012 • in-process
About this view
This batch detail page ties execution evidence, material genealogy, equipment fitness, in-process controls, and quality events into one release-focused view. Users can trace each unit operation against timestamps and investigate linked exceptions without leaving context. The panelized layout supports QA review by exception while preserving full evidence access. Next actions include closing residual issues and completing disposition-ready evidence checks.
Planned
2024-08-20 → 2024-08-24
Actual
2025-04-07 → In progress
Exceptions
25
Release Risk
low
Step Timeline
| Step | Status | Start | End | Result |
|---|
Materials Consumed and Genealogy
| Lot | Material | Status | Genealogy |
|---|---|---|---|
| LOT-012433 | Microcrystalline Cellulose Variant 1 | quarantine | Open workbench |
| LOT-012434 | Lactose Monohydrate Variant 1 | hold | Open workbench |
| LOT-012435 | Hydroxypropyl Methylcellulose Variant 1 | rejected | Open workbench |
Equipment and Calibration
| Asset | Status | Calibration Due | Qualification |
|---|---|---|---|
| AST-01044 Blender #45 | operational | 2025-10-02 | not-qualified |
| AST-01045 Autoclave #46 | in-calibration | 2025-10-23 | qualified |
| AST-01046 Bioreactor #47 | in-maintenance | 2025-07-26 | qualified |
| AST-01047 Centrifuge #48 | out-of-service | 2026-01-16 | qualified |
In-Process Controls and Pending Tests
| Control | Measured | Spec | Status |
|---|
Exceptions and Deviations
| Exception | Severity | Status | Deviation |
|---|---|---|---|
| Equipment Conflict | major | under-review | Not linked |
| Equipment Conflict | major | under-review | Not linked |
| Equipment Conflict | major | under-review | Not linked |
| Equipment Conflict | major | under-review | Not linked |
| Equipment Conflict | major | under-review | dev-00312 |
| Equipment Conflict | major | under-review | dev-01312 |
QA Review Checklist and Signatures
- Step execution completeness verified with signed evidence.
- All high-severity exceptions dispositioned or justified.
- QC release tests reviewed and OOS investigations closed or dispositioned.
- Final release signatory validated with segregation-of-duties check.
No release readiness record found.